Macular Function During Anti-VEGF Treatment (MAFAT Study)

Abstract

Purpose: : To show interim results of a clinical trial (MAFAT study) which evaluates the macular function of patients with neovascular age-related macular degeneration (nAMD) during ranibizumab therapy

Methods: : A one year observational longitudinal prospective single centre study recruiting 20 patients. Inclusion criteria: patients with nAMD undergoing ranibizumab treatment; all types of subfoveal or juxtafoveal choroidal neovascularization (CNV); best corrected visual acuity (BCVA) ≥ 35 letters on the ETDRS charts.Exclusion criteria: spherical equivalent ≥ ± 6 D; any previous treatment for CNV in the study eye; clinical and angiographic signs of fibrosis >75% of the lesion. Macular function is investigated monthly by BCVA and contrast sensitivity (CS), and at baseline, week 1, month 1, 3, 6 and 12 by multifocal electroretinography and microperimetry.Patients receive treatment with 3 consecutive monthly intravitreal ranibizumab injections, followed by a clinician determined re-treatment strategy.

Results: : 12 patients completed 3 month follow-up. Statistical analysis was performed between baseline and month 3 using paired t or Friedman test according to the distribution of data. Mean BCVA (±SD) increased from 56.9 (±14.4) to 65.5 (±12.4) letters (p=0.04). Mean CS (±SD) increased slightly from 28.3 (±3.5) to 30.6 (± 2.) (p=0.04). Mean amplitude (±SD) of p1 of mfERG (ring 1) improved from 27.2 (±13.4) to 48.5 (±16.0) nV/° (p<0.01). At microperimetry mean retinal sensitivity (±SD) at 4°, 8° and 12° increased 5.1 (±5.0), 5.6 (±3.5) and 4.8 (±3.1) dB, respectively (for each degree p<0.01).

Conclusions: : A course of three injections of ranibizumab induces a significant improvement of macular function. The changes appear to be more marked when observed by MP1 and mfERG compared to BCVA suggesting that BCVA may not capture the full functional improvement with therapy and that these additional techniques may give helpful information on the response to treatment.

Clinical Trial: : www.clinicaltrials.gov NCT01023971

Keywords: age-related macular degeneration • electrophysiology: clinical • vascular endothelial growth factor